Understanding Immunity to the Flu Vaccine in COVID-19 Patients

NCT04579588 | Recruiting FDA Drug

• 2 other identifiers: IRB-583565U19AI057229-17
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure immunity to the flu vaccine over time in patients who have had COVID-19 and may have other medical conditions including obesity, type 2 diabetes, chronic fatigue, or long-term COVID-19 symptoms. Adults and children (age 9 to 64) who had been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

Conditions

Corona Virus Infection; Flu Vaccine; Immunity

Outcome Measures

Primary Outcomes (2)

• Testing immunity to the flu vaccine over time

  1 week

• Testing immunity to the flu vaccine over time

  1 month

Study Arms (2)

COVID-19 participants

Biological: Flu shot

Control participants

Biological: Flu shot

Interventions

Flu shot BIOLOGICAL

All participants will receive a single shot of the flu vaccine

COVID-19 participants; Control participants

Eligibility Criteria

• Age: 9 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adults (18-64 years) and children (9-17 years) diagnosed and not diagnosed (controls) with COVID-19 and who may have other medical conditions including long term COVID-19 symptoms, chronic fatigue, type 2 diabetes, and obesity.

You may qualify if:

• Age 9 through 64 years
• Diagnosed with COVID-19 at least 2 months prior enrollment
• Patients with or without obesity, diabetes, chronic fatigue and/or long term COVID-19 symptoms
• Patients without COVID-19 diagnosis for controls

You may not qualify if:

• Received the influenza vaccine less than 4 months ago
• Pregnant or lactating
• Patients with special risks attendant to venipuncture
• Use of immunomodulatory medications that may impact vaccine immune response per clinician's judgment
• Contraindication to the flu vaccine
• Immunodeficiency or autoimmune disease that may impact vaccine immune responses per clinician's judgement

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, stool sample

MeSH Terms

Conditions

Coronavirus Infections; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Orthomyxoviridae Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Sayantani Sindher, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SNP Center Inquiry

CONTACT

(650) 521-7237; snpcenterallergy_inquiry@stanford.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: October 6, 2020
• First Posted: October 8, 2020
• Study Start: October 29, 2020
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)